Demo

Validation Engineer

Katalyst Healthcares and Life Sciences
Rockford, IL Full Time
POSTED ON 2/25/2025
AVAILABLE BEFORE 5/25/2025

Responsibilities :

  • Perform validation activities to ensure compliance with government and customer requirements.
  • Prepare and execute validation protocols (IOQ, OQ / PQ) and related documentation for new customer / product / system launches.
  • Maintain existing validated processes, coordinating internal and customer approvals as needed.
  • Ensure validation documentation is complete, accurate, and properly closed, including organizing and coordinating multiple approvals.
  • Assist in the change control process and prepare change control and validation history reports for audits.
  • Participate in conference calls and meetings to communicate project goals and progress.
  • Investigate validation deviations, document formal reports, and ensure corrective actions are completed.
  • Review and approve User Requirement Specifications (URS), Functional Specifications (FS), and Engineering Study Protocols.
  • Assist with Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment.
  • Coordinate validation efforts with mechanics, operators, and engineering teams.
  • Complete and pass GDP and GMP training courses as required.
  • Perform other duties assigned by managers or supervisors.
  • Manage high-risk projects, which may include complex customer needs, stringent validation requirements, and significant time commitments.

Requirements :

  • Bachelor's degree in a related field or 1-3 years of related experience and / or training.
  • College-level proficiency.
  • Intermediate skills, including proficiency in various technical software programs.
  • Full professional proficiency in speaking, reading, and writing.
  • Experience with medical device sterilization processes and test method validation.
  • Familiarity with GAMP, 21 CFR Part 11, Annex 11 compliance for computer system validation.
  • Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
  • Experience developing, executing, and documenting validation protocols (IOQ, OQ / PQ) for equipment, processes, and computer systems.
  • Preference for medical device experience (Auto-Injector preferred), but candidates with pharma backgrounds will be reviewed.
  • Minimum of 3 years in a regulated industry (FDA, cGMP, pharmaceutical, medical device, or combination products).
  • Understanding of ISO, cGMP, FDA, 21 CFR Part 11, Annex 11, and other regulatory standards.
  • Proficiency in root cause analysis (RCA), CAPA, FMEA, control plans, and process risk management.
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